The FDA has published a new draft guidance on manufacturers' requirements to report certain medical device shortages. The guidance implements section 506J of the Federal Food, Drug, and Cosmetic Act (FDCA) as it relates to notifying the FDA of a permanent discontinuance or interruption in the manufacturing of certain medical devices that is likely to lead to a meaningful disruption in the supply of that device in the U.S. during or in advance of a public health emergency.
The new Draft Guidance helps clarify how the FDA interprets the 506J notification requirements, including who should submit 506J notifications, when to submit a 506J notification, and the information to include in a notification. It is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices.
 | FDA Releases Medical Devices Draft Guidance for Review |
